IUVA Healthcare/ UV Working Group
Troy Cowan director, Vision Based Consulting
UV disinfection devices in healthcare settings bring up questions of which federal regulations apply, where and when. In a hospital setting, thoughts immediately go to the Food and Drug Administration (FDA), which regulates the hospital’s medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA).1 However, there is another player, too – the Environmental Protection Agency (EPA), which regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as explained in EPA’s Pesticide Registration Manual.2
Assuming the discussion is about a UV device, the primary EPA and FDA regulations that apply can be determined by answering a few basic questions.
Is this UV device a regulated disinfection device under EPA?
The EPA defines a pesticide device as “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus or other microorganism on or in living man or living animals)…”3
The EPA’s Pesticide Device Guide further clarifies this to include devices that mitigate “mold/mildew, bacteria and viruses,”4 while excluding “medical instruments or machines used to kill pests in or on living humans or animals…,” regulated by the FDA.5 Another exclusion is “any device that depends more upon the performance of the user than the performance of the device itself to be effective … is not regulated.”6 This exclusion may or may not cover handheld UV disinfection wands.
If a UV device meets this definition, then it is a regulated pesticide device governed by EPA’s FIFRA regulations. As such, pesticide devices are not required to meet any standards but must meet the manufacturer’s claims. More specifically, “false or misleading claims”7 cannot be made about the effectiveness or safety of regulated devices. In short, “If a manufacturer makes claims about a device, they should have scientific data to support the claims.”8 Making claims not supported by scientific data constitutes misbranding and “… distribution or sale of a misbranded device is prohibited under FIFRA.”9 Such misbranding can lead to EPA enforcement actions and possible damage claims by the Federal Trade Commission.10
Other EPA requirements mandate that regulated devices be produced in registered “device-producing establishments”11 that comply with established reporting regulations12 regardless if the unit is produced inside or outside the US.13 Also, regulated devices must be labeled in conformance with EPA labeling requirements.14
That covers the EPA requirements. What about FDA? The FDA is focused on particular devices labeled as Class I, II or III.15 UV devices are typically Class II, primarily found under 21CFR880, “General Hospital and Personal Use Devices.”16
Is this UV disinfection device covered or excluded in FDA regulations?
The answer is simple. If the device is a “self-contained, open chamber, UV radiation disinfection devices intended for whole room disinfection in a healthcare environment,”17 it is excluded from FDA coverage, and only EPA rules apply. That assumes no medical outcome claims are made and no ozone generated; if there are, FDA can claim jurisdiction.18
Is the device regulated by FDA as a ‘UV disinfection chamber’?
FDA covers UV disinfection chambers, defined as “an ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of nonporous equipment surfaces by dose-controlled UV irradiation….”19
If the definition fits the device, it is considered an FDA Class II medical device, subject to the following special control requirements:20
- performance testing of (i) UV dose control, (ii) disinfection performance, (iii) UV compatibility of processed equipment, (iv) cleaning/disinfection procedure validation, (v) performance to spec after cleaning and disinfection and (vi) question of ozone
- performance of software verification, validation and hazard analysis
- validation and/or testing of the electrical safety, mechanical safety and electromagnetic compatibility of the device in its intended use environment
- complete labeling of the device (includes 12 categories of required labeling and explanations)
Is the device regulated by FDA as a ‘medical ultraviolet air purifier’?
FDA regulates medical UV air purifiers, defined as, “A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.”21 If this definition fits, the device is considered an FDA Class II medical device, required to meet FDA performance standards.22 No other requirements are specified.
The FDA does deal very specifically with one safety issue, ozone.
Does the device comply with FDA restrictions on ozone production?
FDA defines ozone as a safety issue in the following way: “(a) Ozone is a toxic gas with no known useful medical application. … In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.”23
So, the question becomes: Does the device produce ozone, and, if so, is it within FDA limits?
FDA’s ozone limits, found in 21CFR801.415(c), state it is a violation of law if any device, “generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air … in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals and offices.”24
The same regulation also says it is a violation of law to have any release of ozone, “into the atmosphere in hospitals or other establishments occupied by the ill or infirmed”25 (it is assumed this means the room is currently occupied, given the wording).
That covers EPA and FDA regulations on UV disinfection devices known to this author. Comments are encouraged, especially specific case studies involving UV regulatory issues. It is important to build a body of UV regulatory knowledge for use by the IUVA membership. Many thanks for observations and contributions to come.
Through the IUVA Healthcare/UV Working Group, endeavors are being made to promote the acceptance of UV disinfecting technologies as a credible, valued part of environmental management throughout the healthcare industry. In this column, the UV community will be updated on these efforts and the latest information on UV technology as it pertains to the healthcare industry.
Contact: Troy Cowan, firstname.lastname@example.org
- EPA’s “Pesticide Registration Manual”
- Same as #1, above.
- EPA Regulation 40CFR152.500, PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURE, Requirements for devices” (https://www.ecfr.gov/cgi-bin/text-idx?SID=7302063a269d9db294e73ca3971a1e33&mc=true&node=se40.26.152_1500&rgn=div8)
- EPA’s “Pesticide Devices: A Guide for Consumers” (https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers#9)
- Same as #5, above
- Same as #5, above
- EPA Regulation 156.10(a)(5) “False or misleading statements” (https://www.ecfr.gov/cgi-bin/text-idx?SID=10a101986c7fe136742396a6c0eed0f6&mc=true&node=se40.26.156_110&rgn=div8)
- Same as #8, above
- Same as #8, above.
- Cowan and Martinello, “Panel Discussion: Fighting HAIs and MDROs with UV-C Using Industry, Health Care and Federal Collaboration” (https://iuvanews.com/stories/pdf/archives/190204-IUVA_News_Summer2017_final_PanelDiscussion.pdf )
- EPA Regulations 40CFR167.20, “Establishments requiring registration” (https://www.ecfr.gov/cgi-bin/text-idx?SID=2e83a1530ce4759d881e53a99f9352a6&mc=true&node=se40.26.167_120&rgn=div8)
- EPA Regulation 40CFR167.85 “Recordkeeping and Reporting Requirements” (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=2e83a1530ce4759d881e53a99f9352a6&mc=true&n=pt40.26.167&r=PART&ty=HTML#se40.26.167_185)
- EPA Regulations 40CFR167.20(a)(1) and (3) – see above
- Same as #8, above
- FDA Guidance, “Classify Your Medical Device”, (https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device )
- FDA Regulation 21CFR 880, “General Hospital And Personal Use Devices” (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=880)
- FDA Regulation 21CFR880.6600(a), “… (UV) radiation chamber disinfection device – Identification” (https://www.ecfr.gov/cgi-bin/text-idx?SID=0e074ddfdd2725b1e9c6a3aa5fdc9791&mc=true&node=pt21.8.880&rgn=div5#se21.8.880_16600 )
- FDA 21 C.F.R. § 814.80, “Premarket Approval of Medical Devices – Postapproval Requirements” (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&showFR=1&subpartNode=21:18.104.22.168.11.5 )
- Same as #10, above
- FDA Regulation 21CFR880.6600 “Ultraviolet (UV) radiation chamber disinfection device – Classification” (https://www.ecfr.gov/cgi-bin/text-idx?SID=0e074ddfdd2725b1e9c6a3aa5fdc9791&mc=true&node=pt21.8.880&rgn=div5#se21.8.880_16600 )
- FDA Regulation 21CFR880.6500 “Medical ultraviolet air purifier” (https://www.ecfr.gov/cgi-bin/text-idx?SID=0e074ddfdd2725b1e9c6a3aa5fdc9791&mc=true&node=pt21.8.880&rgn=div5#se21.8.880_16600 )
- Same as #13, above
- FDA Regulation 21 CFR 801.415 “Maximum acceptable level of ozone,” sub-para. (a (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?fr=801.415 )
- FDA Regulation 21 CFR 801.415 “Maximum acceptable level of ozone,” sub-para. (c (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?fr=801.415 )
- Same as #25, above